The Union health ministry has banned the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 milligrams (mg) for human use, citing health risks.
This comes after a similar recommendation was made by the Indian Council of Medical Research (ICMR) in a report, amid concerns that it could cause liver damage, life-threatening in some cases.
'The central government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use,' a government notification released late on December 30 stated.
India had already banned nimesulide usage for kids under 12 after receiving reports of severe hepatotoxicity in several young patients globally and locally. Its use was subsequently banned for veterinary purposes in February this year.
The extra caution comes after the ICMR report had highlighted a poor safety profile for the drug in adults, suggesting that it be reserved only as a second-line treatment and should be used only after all first-line options have been tried and found ineffective.
While some experts considered recommending a nationwide ban on nimesulide, the Drug Technical Advisory Board under India's apex drug regulator asked the ICMR to carry out a systematic review of nimesulide use in kids under 12, those between 12 and 18 and the 60-plus groups before further deliberations.
While affirming the prohibition of the drug in immediate-release dosage forms, the DTAB 'opined that nimesulide is one of the effective drugs for reducing fever and used for short-term treatment', according to the minutes of its 92nd meeting held in April 2025.
Launched in Italy in 1985, nimesulide belongs to a class of drugs, non-steroidal anti-inflammatory drugs (NSAIDs), which are commonly used to relieve pain and reduce fever.
India approved nimesulide in 1995 and currently boasts of a market of around Rs 500 crore on a moving annual turnover basis, according to estimates.
On the other hand, countries such as the United States, the United Kingdom, Spain, Australia, Canada, Japan, and New Zealand, among others, have never approved the drug due to safety concerns.
© 2026